Health TrialsbyHealthPanel

HOnest Placebos With Explanations: Evaluating Open-Label Placebos for Chronic Pain

ConditionsChronic Low-back PainChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorRhode Island Hospital

About this trial

The goal of this clinical trial is to examine the effect of rationale condition when taking open-label placebos on pain by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other. We also aim to examine the effect of rationale condition on prescription opioid use by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other.

This study will include patients with chronic low back pain. The main question it aims to answer is:

How do rationales influence the effects of open-label placebos?

Researchers will compare different rationales given when taking an open-label placebo and a no-treatment group and a no rationale group taking OLPs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

chronic pain (pain lasting at least 3 months, pain intensity 4/10 or over and interference 3/10 or over)

at least 18 years old

English speaking

have a smartphone or computer with video access

Disqualifiers

Have chronic pain because of a cancer diagnosis

Over 89 years of age

Suspect an allergy to any placebo ingredient

Currently receiving worker's compensation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Open-label Placebo

    Drug

    Open-label placebo pill for 21 days at 2 per day

  • Standard Rationale

    Behavioral

    Scientific rationale about the placebo effect

  • Mindfulness

    Behavioral

    Mindfulness based rationale

  • Control Rationale

    Behavioral

    Basic epidemiological information about chronic pain to achieve structural equivalence for the control groups

Treatment groups

340 Participants
are divided into 4 treatment groups
Group A: OLP + Standard RationaleExperimental treatment 2 interventions
Group B: OLP + Mindfulness RationaleExperimental treatment 2 interventions
Group C: OLP + Control RationalePlacebo comparator 2 interventions
Group D: No Treatment + Control RationaleSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain intensity

Single-item assessing current pain level from 0 (min value) to 10 (max value). Higher scores indicate more pain intensity

Time frame
across 42 days

Secondary outcomes

1

Pain interference

Pain Interference subscale from Brief Pain Inventory Pain interference is measured for general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life on a 0-10 NRS with 0 = "does not interfere" and 10 = "completely interferes" Higher scores indicated greater pain intensity or greater interference with function.

Time frame
across 42 days
2

Pain catastrophizing

Single item assessing how much the patient catastrophizes about their pain from 0 (minimum) to 10 (maximum). Higher scores indicate more catastrophizing. 13 items rated on 5-point Likert scales, from (0) not at all to (4) all the time Higher score indicates higher level of catastrophizing Item scores are summed into a total score (PCS-T) and three subscale scores: * Rumination (PCS-R): Items 8, 9, 10, and 11 * Magnification (PCS-M): Items 6, 7, 13 * Helplessness (PCS-H): Items 1, 2, 3, 4, 5, and 12 Minimum total score = 0, maximum total score = 52 Subscale score ranges: PCS-R: 0-16; PCS-M: 0-12; PCS-H: 0-24 A total score above 30 indicates clinically relevant level of catastrophizing

Time frame
across 42 days
3

Prescription Medication use (including opioids)

Time frame
across 42 days

Other outcomes

1

Placebo use

Time frame
across 21 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rhode Island Hospital

Lead sponsor

Source ClinicalTrials.gov
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